Clinical Trials Logo

Clinical Trial Summary

1 in 7 babies require neonatal care. During their time in hospital their vital signs (such as heart rate, breathing rate and oxygen saturation) are continuously monitored as part of standard care. Many factors lead to changes in vital signs, for example, medical procedures such as blood tests can result in brief increases in heart rate. Medication can also alter vital signs, either as an intended effect or as a side effect. However, different infants will respond in different ways to both procedures and medication. Predicting how an individual infant may respond could lead to better individualised care for infants. For example, using an infant's baseline vital signs to predict whether they will experience cardiorespiratory side effects from a particular drug could mean that doctors could choose an alternative safer treatment plan. To develop these predictive models, it is essential to first better understand how infants' vital signs are affected by different procedures and drugs, and how these effects are impacted by other factors such as infection, other pathologies, interaction between drugs and age. Despite their routine use in hospital neonatal units, detailed electronic records of vital signs are often not recorded. Often, only major events or average values are stated on clinical records. Subtle changes in vital signs are therefore missed, and more complex analysis that may reveal important predictive features within the data is not possible. In this study the investigators will electronically record infant vital signs across longer time periods and during a variety of clinically-necessary procedures and administration of drugs, to explore how these impact vital signs and are altered by factors such as age and pathology. These will be compared with control procedures, such as a nappy change, or when the infant is resting in their cot or receiving skin-to-skin care.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06032494
Study type Observational
Source University of Oxford
Contact Caroline Hartley, PhD
Phone +44 1865 234537
Email caroline.hartley@paediatrics.ox.ac.uk
Status Recruiting
Phase
Start date September 20, 2023
Completion date September 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06350084 - Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection N/A
Not yet recruiting NCT04441463 - Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth (TryPla) N/A
Not yet recruiting NCT04337229 - Evaluation of Comfort Behavior Levels of Newborns With Artificial Intelligence Techniques N/A
Completed NCT01732978 - Are Parents Privileged Listeners Their Baby ? N/A
Unknown status NCT01029496 - Immediate VS Delayed Cord Clamping on Newborns Phase 1/Phase 2
Completed NCT03690804 - Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units N/A
Completed NCT05064683 - The Effect of Facilitated Tucking and White Noise on Stress and Sleep of Newborns in Nasal CPAP N/A
Completed NCT04827849 - Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby N/A
Not yet recruiting NCT03630575 - Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study N/A
Recruiting NCT03109444 - Normative Radiographic Parameters and Growth Curve of Hips Less Than Six Weeks of Gestational Age Using Ultrasound
Not yet recruiting NCT06053931 - The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort N/A
Completed NCT04869176 - Effect of Caffeine on Heart Rate Variability in Newborns N/A
Not yet recruiting NCT05109481 - Masks and Visual Preferences in the Newborn
Completed NCT05103800 - Investigation of the Effect of White Noise Listening on Pain and Comfort During Invasive Interventions in Newborns N/A
Completed NCT03047967 - Effects of Prenatal Tobacco Smoke Exposure on Lung Function and Respiratory Epithelium Functionality in Newborns N/A
Not yet recruiting NCT06418815 - Concept Map on Toxic Stress in Newborns N/A
Completed NCT03969459 - Impact of Exposure to Persistent Organic Pollutants During Pregnancy on the Composition of Breast Milk and Consequences on the Newborn
Completed NCT06352918 - Peripheral Central Catheter (PICC) Care N/A
Completed NCT05442619 - Developing a Portable Therapeutic Baby Nest for Newborns and Evaluation During Venous Blood Collection N/A
Not yet recruiting NCT03112798 - Miller vs Macintosh Size 0 Blades for Tracheal Intubation of Infants N/A